ASEPT 622273
GUDID 04046964317149
ASEPT 1000ML BOTTLE W/O DRAIN LINE
B BRAUN INTERVENTIONAL SYSTEMS, INC
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| NIH Device Record Key | 467ac7a2-efea-42f1-a6f0-5bbd91c70124 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASEPT |
| Version Model Number | 622273 |
| Catalog Number | 622273 |
| Company DUNS | 784259751 |
| Company Name | B BRAUN INTERVENTIONAL SYSTEMS, INC |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964317125 [Unit of Use] |
| GS1 | 04046964317149 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K001716
FDA Product Code
| JCX | APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-11-02 |
| Device Publish Date | 2016-03-04 |
On-Brand Devices [ASEPT]
| 04046964317514 | ASEPT PLEURAL DRAINAGE SYSTEM |
| 04046964317330 | ASEPT PERITONEAL DRAINAGE SYSTEM |
| 04046964317149 | ASEPT 1000ML BOTTLE W/O DRAIN LINE |
Trademark Results [ASEPT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASEPT 88598012 not registered Live/Pending |
PFM MEDICAL, INC. 2019-08-29 |
 ASEPT 85138106 4015067 Live/Registered |
PFM Medical, Inc. 2010-09-24 |
 ASEPT 76186686 3310210 Live/Registered |
ASEPT INTERNATIONAL AB 2000-12-22 |
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